(42 days)
Not Found
No.
The document mentions "data and image processing," but it does not specifically state that these processes involve AI models. The "Mentions AI, DNN, or ML" section is marked "Not Found," and there is no description of AI training or validation in the provided text.
No
This device is clearly described as an imaging system (CT scanner) intended for producing cross-sectional images for diagnostic purposes. Its primary function is to acquire data and generate images of internal structures to aid in the diagnosis of disease or abnormality and for planning therapy procedures, rather than directly treating a condition.
Yes
The device explicitly states that "The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures." It also mentions its indication for "x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies" and for "low dose CT for lung cancer screening," all of which are diagnostic applications.
No
The device is described as an expansion of an X-ray Computed Tomography system's capabilities for low-dose lung cancer screening. It explicitly references hardware components like "CT systems," "scan protocols," and "SpotLight / SpotLight Duo scanners." While it involves data and image processing, it's integral to a physical imaging device, not a standalone software application. The clearance is for an "option" on an existing hardware system, not a software-only device.
No.
Reasoning: The device is an X-ray Computed Tomography system used to produce images of the body. It does not perform tests on biological samples collected from the body.
N/A
Intended Use / Indications for Use
The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view.
The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) – resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) – Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option.
The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.
The SpotLight Computed Tomography X-ray system is intended for head, body, cardiac and vascular X-ray computed tomography applications.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The Low Dose Lung Cancer Screening (LD LCS) option indication for Arineta's SpotLight and SpotLight Duo scanners is being expanded to include small patients, as defined by AAPM (American Association of Physicists in Medicine). This expansion ensures comprehensive coverage of the intended lung cancer screening population, following the previous clearance of the LD LCS option for medium and large patients under K241200.
The proposed LD LCS option for the SpotLight and SpotLight Duo includes scan protocols with CTDI that comply with AAPM's requirements for the whole LD LCS population patient size groups, as detailed in the following table:
| Patient Size (AAPM group) | Weight (Kg) | CTDI (mGy) | SpotLight / SpotLight Duo - Indication for Use |
|---|---|---|---|
| Small | 50-70 Kg | 0.25-2.8 mGy | Proposed Device |
| Medium | 70-90 Kg | 0.5-4.3 mGy | K241200 |
| Large | 90-120 Kg | 1.0-5.6 mGy | K241200 |
There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied.
The proposed full LD LCS protocols option, as the cleared K241200, will be activated by service or production personnel, with no additional installation required (option activation only).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission projection data
Computed Tomography (CT)
Anatomical Site
Cardiovascular and thoracic anatomies, including the heart.
Head, body.
Indicated Patient Age Range
Patients of all ages (DLIR is limited for patient use above the age of 2 years).
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
To confirm that small patient LCS group images (50-70kg,
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
FDA 510(k) Clearance Letter - SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 15, 2025
Arineta Ltd.
℅Tanya Shalem
VP QA & RA
15 Halamish St.
Caesarea, 3088900
ISRAEL
Re: K250650
Trade/Device Name: SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed Tomography X-Ray System
Regulatory Class: Class II
Product Code: JAK
Dated: March 3, 2025
Received: March 4, 2025
Dear Tanya Shalem:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K250650 - Tanya Shalem Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K250650 - Tanya Shalem Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Lu Jiang
Assistant Director
DHT8B: Division of Radiologic Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250650
Device Name: SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Indications for Use (Describe)
The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view.
The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) – resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) – Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option.
The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
510(k) Summary
Arineta's SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
I. SUBMITTER
Arineta Ltd.
15 Halamish Street
Caesarea 3088900 Israel
Phone: +972-4-6374000
Contact Person: Tanya Shalem, VP of Q&R, E-mail: tanya.shalem@arineta.com
510(k) Number: K250650
Date Prepared: Mar 03, 2025
II. DEVICE
Name of Device: SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Common Name: System, X-ray, Tomography, Computed
Classification Name: Computed tomography x-ray system
Regulation Number: 892.1750
Product Code(s): JAK
III. PREDICATE DEVICE
Predicate Device Name: SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Manufacturer: Arineta Ltd.
510(k) Number: K241200
Common Name: System, X-ray, Tomography, Computed
Classification Name: Computed tomography x-ray system
Regulation Number: 892.1750
Product Code(s): JAK
Page 6
IV. DEVICE DESCRIPTION
The Low Dose Lung Cancer Screening (LD LCS) option indication for Arineta's SpotLight and SpotLight Duo scanners is being expanded to include small patients¹, as defined by AAPM (American Association of Physicists in Medicine). This expansion ensures comprehensive coverage of the intended lung cancer screening population, following the previous clearance of the LD LCS option for medium and large patients under K241200.
The proposed LD LCS option for the SpotLight and SpotLight Duo includes scan protocols with CTDI that comply with AAPM's requirements for the whole LD LCS population patient size groups, as detailed in the following table:
| Patient Size (AAPM group) | Weight (Kg) | CTDI (mGy) | SpotLight / SpotLight Duo - Indication for Use |
|---|---|---|---|
| Small | 50-70 Kg | 0.25-2.8 mGy | Proposed Device |
| Medium | 70-90 Kg | 0.5-4.3 mGy | K241200 |
| Large | 90-120 Kg | 1.0-5.6 mGy | K241200 |
There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied.
The proposed full LD LCS protocols option, as the cleared K241200, will be activated by service or production personnel, with no additional installation required (option activation only).
V. INTENDED USE
The SpotLight Computed Tomography X-ray system is intended for head, body, cardiac and vascular X-ray computed tomography applications.
VI. INDICATIONS FOR USE
The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes.
The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view.
¹ Note: The "small patients" subgroup discussed in this submission includes adults eligible for Lung Cancer Screening (LCS) with a weight range of 50 to 70 kg.
Page 7
The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) – resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) – Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option.
The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.
VII. INDICATIONS FOR USE COMPARISON
The proposed devices maintain the same intended use. The modification involves a minor update to the indications for use, expanding the Low Dose (LD) Lung Cancer Screening (LCS) patient population to include all relevant groups. This includes the addition of small patient protocols, as defined by AAPM guidelines (50-70 kg, 70 kg), as defined by AAPM, included in the cleared K241200 clinical assessment, were identified as the 'worst-case' scenario for performance evaluation. This designation was based on increased X-ray attenuation with an expected reduction in image quality for larger patients, and the predominance of larger patients within the LD LCS-eligible population distribution.
To confirm that small patient LCS group images (50-70kg,